A blood sample protective agent for hypertension and a vacuum blood collection tube for detecting hypertension blood sample and application

Abstract

The application provides a high blood pressure blood sample protective agent, a vacuum blood collection tube for high blood pressure blood sample detection and application, and belongs to the technical field of medical devices. The high blood pressure blood sample protective agent is characterized in that raw materials of the high blood pressure blood sample protective agent include enalapril maleate, an anticoagulant and a complexing agent in terms of weight parts. The vacuum blood collection tube for high blood pressure blood sample detection has the high blood pressure blood sample protective agent. The application is to directly save blood by using the vacuum blood collection tube for high blood pressure blood sample detection. The vacuum blood collection tube for high blood pressure blood sample detection can reduce the cumbersome steps of reagent preparation and on-site reagent addition, thereby improving the detection efficiency and the accuracy of the detection result.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a blood sample preservative for hypertension and a vacuum blood collection tube for hypertension blood sample detection and its application, especially a blood sample preservative for hypertension and angiotensin I and angiotensin II detection and a vacuum blood collection tube for hypertension blood sample detection and its application. Background Technology

[0002] With the continuous increase in the prevalence of hypertension and the rising mortality rate from cardiovascular and cerebrovascular diseases, people are paying increasing attention to the prevention, detection, and treatment of hypertension. Commonly used indicators for hypertension detection include plasma renin, plasma adrenocorticotropic hormone (ACTH), plasma angiotensin II, plasma aldosterone, and plasma cortisol. The renin-angiotensin-aldosterone (RAAS) system is an important system for regulating water and electrolyte metabolism and maintaining circulating blood pressure. Renin is secreted by the juxtaglomerular cells of the renal arterioles. Renin catalyzes the conversion of angiotensinogen secreted by the liver into angiotensin I. Angiotensin I can be degraded into angiotensin II by angiotensin-converting enzymes from lung epithelial cells in the pulmonary circulation.

[0003] To block the conversion of angiotensin I and angiotensin II and maintain their relatively stable concentrations for accurate detection, anticoagulants, enzyme inhibitors, and chelating agents are added to the blood collection tubes after blood collection. Preventing the conversion of angiotensin I and angiotensin II is a common sample pretreatment method for detecting angiotensin I and angiotensin II. Currently, most commercially available test kits use a sample pretreatment method where, after collecting venous blood using an anticoagulant tube, the inhibitor is added after opening the cap. This procedure not only increases testing time but also fails to standardize blood collection procedures, easily introducing significant errors into the test results.

[0004] However, existing vacuum blood collection tubes cannot provide enzyme inhibitors for blood collection in cases of hypertension, so they are not fully suitable for testing blood samples with hypertension. Summary of the Invention

[0005] The purpose of this invention is to solve the problem that existing vacuum blood collection tubes are not fully applicable to hypertension blood testing, and to provide a hypertension blood sample protectant, a vacuum blood collection tube for hypertension blood sample testing, and its application.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0007] A blood sample protectant for hypertension, comprising, by weight, 1-1.3 parts enalapril maleate, 15.2-18.6 parts anticoagulant, and 13.8-16.9 parts complexing agent.

[0008] Furthermore, the complexing agents are imidazolidinyl urea and 8-hydroxyquinoline sulfate.

[0009] Furthermore, the weight ratio of imidazolidinyl urea to 8-hydroxyquinoline sulfate is 7.5–9.2:6.3–7.7.

[0010] Furthermore, the anticoagulant includes dipotassium ethylenediaminetetraacetate.

[0011] Furthermore, the method for preparing the hypertension blood sample protectant is to dissolve enalapril maleate, an anticoagulant, and a chelating agent in water for injection.

[0012] Furthermore, the hypertension blood sample protectant contains 15.2–18.6 g / 100 mL of dipotassium ethylenediaminetetraacetate, 7.5–9.2 g / 100 mL of imidazolidinyl urea, 6.3–7.7 g / 100 mL of 8-hydroxyquinoline sulfate, and 1.0–1.3 g / 100 mL of enalapril maleate.

[0013] A vacuum blood collection tube for detecting blood samples with hypertension, wherein the vacuum blood collection tube for detecting blood samples with hypertension contains the aforementioned blood sample protectant.

[0014] Furthermore, when the vacuum blood collection tube for hypertension blood sample testing is 3 mL, 34.0–41.6 μL of the hypertension blood sample protectant is sprayed on it; when the tube is 5 mL, 56.7–69.3 μL of the hypertension blood sample protectant is sprayed on it; for other sizes, the corresponding amount of hypertension blood sample protectant is sprayed on it according to the proportion.

[0015] An application of a vacuum blood collection tube for hypertension blood sample testing, wherein the application involves directly storing blood using the aforementioned vacuum blood collection tube for hypertension blood sample testing.

[0016] Furthermore, during the blood preservation process, the volume ratio of the hypertension blood sample preservative to the blood is 1:50 to 100.

[0017] The beneficial effects of the present invention, including a blood sample preservative for hypertension, a vacuum blood collection tube for hypertension blood sample testing, and its application, are as follows:

[0018] The blood sample protectant of the present invention uses enalapril maleate instead of conventional enzyme inhibitors, and is combined with anticoagulants and chelating agents, and can be directly used for blood sample collection of angiotensin I and angiotensin II.

[0019] This invention uses enalapril maleate instead of conventional enzyme inhibitors as the enzyme inhibitor of this invention, which can inhibit angiotensin-converting enzyme, thereby blocking the process of angiotensin I converting to angiotensin II; at the same time, the use of 8-hydroxyquinoline sulfate as a metal ion chelating agent can inhibit the activity of angiotensin-converting enzyme by chelating zinc ions, thereby improving the detection efficiency and accuracy of blood samples with hypertension.

[0020] Using the vacuum blood collection tube for hypertension blood sample testing of the present invention can reduce the cumbersome steps of reagent preparation and on-site reagent addition, thereby improving the detection efficiency and accuracy of the test results; and no conventional enzyme inhibitors need to be added during the entire detection process, which can reduce the detection cost of vacuum blood collection tubes for hypertension blood sample testing. Attached Figure Description

[0021] Figure 1 This is a simplified structural diagram of the vacuum blood collection tube used for hypertension blood sample detection in Embodiment 1 of the present invention. Detailed Implementation

[0022] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention may also be implemented in other ways different from those described herein. Those skilled in the art can make similar extensions without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0023] Example 1: A blood sample preservative for hypertension and a vacuum blood collection tube for hypertension blood sample detection. I. Preparation of the blood sample preservative for hypertension.

[0024] 1) Formula

[0025] A blood sample protectant for hypertension contains 16.9 g / 100 mL of dipotassium ethylenediaminetetraacetate, 8.4 g / 100 mL of imidazolidinyl urea, 6.9 g / 100 mL of 8-hydroxyquinoline sulfate, and 1.2 g / 100 mL of enalapril maleate, with sterile water for injection as the solvent.

[0026] 2) Preparation method

[0027] Calculate the amount of reagents required for 100mL of hypertension blood sample preservative according to the above formula. Weigh out dipotassium ethylenediaminetetraacetate, imidazolidinyl urea, 8-hydroxyquinoline sulfate and enalapril maleate according to the weighing requirements and add them to a beaker. Measure an appropriate amount of sterile water for injection to completely dissolve the reagents, then pour the solution into a 100mL volumetric flask and dilute to the mark with sterile water for injection to obtain the hypertension blood sample preservative.

[0028] II. Vacuum blood collection tubes used for hypertension blood sample testing

[0029] 1) Structure of vacuum blood collection tubes used for hypertension blood sample testing

[0030] like Figure 1As shown, a vacuum blood collection tube for hypertension blood sample testing comprises a rubber stopper, a cap, a label, a test tube, and the aforementioned hypertension blood sample preservative. The hypertension blood sample preservative is located inside the test tube. The rubber stopper is tightly sealed to the opening of the test tube, and a cap is attached to the outside of the rubber stopper. The label is affixed to the outside of the test tube. The test tube is a plastic tube made of PET. The rubber stopper is made of halogenated butyl rubber, and the cap is made of PE or HDPE plastic.

[0031] 2) Preparation method of vacuum blood collection tubes for hypertension blood sample testing

[0032] A blood sample preservative for hypertension was sprayed into the test tube, and vacuum blood collection tubes containing the preservative were prepared according to the traditional vacuum blood collection tube manufacturing process. Specifically, 37.8 μL of the preservative was sprayed onto 3 mL vacuum blood collection tubes for hypertension blood sample testing, 63 μL onto 5 mL tubes, and other sizes of vacuum blood collection tubes were sprayed with the appropriate amount of preservative according to the specified ratio.

[0033] III. Application of Vacuum Blood Collection Tubes for Hypertension Blood Sample Detection

[0034] During the use of vacuum blood collection tubes for hypertension blood sample testing, the volume ratio of the hypertension blood sample preservative to the blood sample is 1:50-100, preferably 1:80. When the blood sample is directly introduced into the vacuum blood collection tube for hypertension blood sample testing, it is inverted and mixed thoroughly. The vacuum blood collection tube for hypertension blood sample testing is pre-filled with the hypertension blood sample preservative, which reduces the cumbersome steps of reagent preparation and on-site reagent addition, thereby improving testing efficiency and the accuracy of test results. The test tube is then capped with a rubber stopper, evacuated, and labeled.

[0035] Example 2: An application of a vacuum blood collection tube for hypertension blood sample detection

[0036] I. Blood Collection

[0037] Blood samples were stored and tested using both vacuum blood collection tubes (used for hypertension testing) and regular blood collection tubes, as detailed below:

[0038] Thirty volunteers underwent routine blood collection, with 5 mL of blood drawn from the antecubital vein. Three tubes were collected from each volunteer: one for the experimental group, one for the control group, and one for the negative control group. For the experimental group, the blood sample was directly collected into the vacuum blood collection tubes for hypertension testing (as described in Example 1), inverted several times, and immediately placed in an ice-water bath or a 4°C refrigerator for 1–2 hours. For the control group, after needle removal, the blood was added to an anticoagulant tube (i.e., a vacuum blood collection tube containing anticoagulant). The tube cap was opened, and 25 μL of 0.32 M dimercaprol solution and 50 μL of 0.34 M 8-hydroxyquinoline sulfate were added according to the kit instructions. The tube was sealed, inverted several times to mix, and immediately placed in an ice-water bath or a 4°C refrigerator for 1–2 hours. This tube served as the control group's blood collection tube. After the needle is removed from the blood collection for the negative control group, the blood is added to an anticoagulant tube (i.e., a vacuum blood collection tube containing an anticoagulant) containing an anticoagulant (EDTA-K2 or EDTA-Na2). The tube cap is opened, and 50 μL of 0.34M 8-hydroxyquinoline sulfate is added according to the kit instructions. The tube is then sealed and inverted several times to mix. The tube is then immediately placed in an ice-water bath or a 4°C refrigerator for 1–2 hours. This tube serves as the negative control group blood collection tube.

[0039] The kit used for the anticoagulant tubes includes:

[0040] The kit for determining angiotensin I (chemiluminescence method) includes: magnetic microspheres, luminescent markers, low-point calibrators, high-point calibrators, and quality control materials; auxiliary reagents include: anticoagulant, enzyme inhibitor, pH adjuster, and 0.32M dimercaprol solution.

[0041] The kit for determining angiotensin II (chemiluminescence method) includes: kit: magnetic microspheres, luminescent marker, low-point calibrator, high-point calibrator, quality control; auxiliary reagents: anticoagulant, enzyme inhibitor, 0.32M dimercaprol solution.

[0042] All the above reagent kits were provided by Shenzhen New Industries Biomedical Engineering Co., Ltd.

[0043] The anti-coagulation tubes are prepared as follows:

[0044] For every 5 mL of blood drawn, add 50 μL of 0.3 M EDTA dipotassium (anticoagulant), 25 μL of 0.32 M dimercaprol solution, and 50 μL of 0.34 M 8-hydroxyquinoline sulfate to each blood collection tube. After preparation, seal and store at 2–8°C for up to one week. Alternatively, pre-contained blood collection tubes can be used. When preparing these, simply add 0.32 M dimercaprol solution and 8-hydroxyquinoline sulfate according to the specified ratio; do not add 0.3 M EDTA dipotassium (anticoagulant). After preparation, seal and store at 2–8°C for up to one week.

[0045] If anticoagulant tubes are not prepared, blood can be collected using blood collection tubes without any additives. After removing the needle, open the tube cap and add the following solutions in the correct proportions: 0.3M dipotassium EDTA (anticoagulant) (if using anticoagulant tubes containing EDTA, the anticoagulant provided in the kit is not required), 0.32M dimercaprol solution, and 0.34M 8-hydroxyquinoline sulfate.

[0046] After preparing the above samples, proceed with the test according to the kit's experimental method. After preparation, perform pipetting and incubation, calibration, quality control, analytical procedures, calculations, and results.

[0047] II. Plasma Treatment

[0048] 1) Take the blood collection tubes of the experimental group, the blood collection tubes of the control group and the negative control group out of the ice water bath or 4℃ refrigerator, centrifuge at 1700g for 10min to separate the plasma and obtain the corresponding plasma samples.

[0049] 2) The angiotensin I content was measured in plasma samples from the experimental group, control group, and negative control group of the same patients, as detailed below:

[0050] Angiotensin I (Angiotensin I) level measurement is essentially a test to determine the rate of angiotensin I production in plasma, reflecting plasma renin activity (PRA). Two copies of the same plasma sample are taken. One copy is reacted directly with an antibody at 2-8°C, and its angiotensin I concentration is measured; this is called the control tube. The other copy is incubated at 37°C for a period of time before reacting with the antibody, and its angiotensin I concentration is measured; this is called the test tube. The angiotensin I concentration in the test tube minus the angiotensin I concentration in the control tube, divided by the incubation time, gives the rate of angiotensin I production per unit time, known as renin activity (PRA).

[0051] Plasma samples were removed from the blood collection tubes and divided into two portions, placed in 12*75mm PET tubes. pH adjuster was added to each portion according to the proportions specified in the anticoagulant kit, and the mixture was thoroughly combined. One plasma sample was placed on ice, while the other was incubated at 37°C for 1 hour and then immediately placed on ice. The testing procedure and steps were performed according to the instructions of the anticoagulant kit. No enzyme inhibitors were added to either the experimental or negative control groups, while the control group received the normal amount of enzyme inhibitors. The results are shown in Table 1.

[0052] Table 1. Results of angiotensin I-responsive plasma renin activity (PRA) analysis

[0053]

[0054]

[0055] A T-test was performed on the measured values ​​of the three groups of samples. The P-value between the experimental group and the control group was 0.7252, which is greater than 0.05, indicating no significant difference. The correlation coefficient between the measured values ​​was 0.9884. The P-value between the negative control group and the control group was 0.0001, which is less than 0.05, indicating a significant difference. The correlation coefficient between the measured values ​​was 0.6995. It can be considered that the vacuum blood collection tube for hypertension blood sample detection provided by this invention is suitable for the determination of angiotensin I by chemiluminescence immunoassay. However, the negative control without added enzyme inhibitors is not suitable for the determination of angiotensin I by chemiluminescence immunoassay.

[0056] 3) The angiotensin II content was measured in plasma samples from the experimental group, control group and negative control group of the same patients according to the instructions of the kit used for the anticoagulant tube. No enzyme inhibitor was added to the experimental group and the negative control group, while the control group was given enzyme inhibitor as normal. The measurement results are shown in Table 2.

[0057] Table 2. Angiotensin II Analysis Results

[0058]

[0059]

[0060] A T-test was performed on the measured values ​​of the three groups of samples. The P-value between the experimental group and the control group was 0.9638, which is greater than 0.05, indicating no significant difference, and the correlation coefficient between the measured values ​​was 0.9806. The P-value between the negative control group and the control group was 0, which is less than 0.05, indicating a significant difference, and the correlation coefficient between the measured values ​​was 0.4137. It can be considered that the vacuum blood collection tube for hypertension blood sample detection provided by this invention is suitable for the determination of angiotensin II by chemiluminescence immunoassay, but the negative control without added enzyme inhibitors is not suitable for the determination of angiotensin II by chemiluminescence immunoassay.

[0061] Example 3: An application of a vacuum blood collection tube for hypertension blood sample detection

[0062] I. Blood Collection

[0063] Since this experiment focuses on the effect of blood collection time, and in accordance with the requirements of the kit for the use of blood collection tubes, anticoagulant tubes were still selected for blood collection in both the control and positive control groups to prevent blood clotting caused by using additive-free vacuum blood collection tubes.

[0064] Blood samples were stored and tested using both vacuum blood collection tubes (used for hypertension testing) and regular blood collection tubes, as detailed below:

[0065] Thirty volunteers underwent routine blood collection, with 5 mL of blood drawn from the antecubital vein. Three tubes were collected from each volunteer: one for the experimental group, one for the control group, and one for the positive control group. For the experimental group, the blood sample was directly collected into the vacuum blood collection tubes for hypertension testing (as described in Example 1), inverted several times, and immediately placed in an ice-water bath or a 4°C refrigerator for 2 hours. For the control group, after needle removal, the blood was added to an anticoagulant tube containing anticoagulant (EDTA-K2 or EDTA-Na2). The tube cap was immediately opened, and 25 μL of 0.32 M dimercaprol solution and 50 μL of 0.34 M 8-hydroxyquinoline sulfate were added according to the kit instructions. The tube was then sealed, inverted several times to mix, and immediately placed in an ice-water bath or a 4°C refrigerator for 2 hours. This tube served as the control group's blood collection tube.

[0066] After the needle was removed from the positive control group, the blood was added to an anticoagulant tube containing anticoagulant (EDTA-K2 or EDTA-Na2). The tube was immediately placed in an ice-water bath or a 4°C refrigerator for 1 hour. Then, the tube cap was opened, and 25 μL of 0.32 M dimercaprol solution and 50 μL of 0.34 M 8-hydroxyquinoline sulfate were added according to the kit instructions. The tube was then sealed and inverted several times to mix. The tube was then immediately placed in an ice-water bath or a 4°C refrigerator for 1 hour. This tube served as the positive control group blood collection tube.

[0067] The anticoagulant tubes and the kits used in this embodiment are the same as those in Example 2.

[0068] II. Blood Sample Processing

[0069] The levels of angiotensin I and angiotensin II in plasma samples from the same patients were measured using the following methods: (Experimental group blood collection tubes, control group blood collection tubes, and positive control group blood collection tubes).

[0070] 1) Take out the blood collection tubes from the experimental group, control group and positive control group after the storage time, 1700g, centrifuge for 10min, separate the plasma, and obtain the corresponding plasma samples.

[0071] 2) Angiotensin I levels were measured in plasma samples from the experimental group, control group, and positive control group of the same patients, as detailed below:

[0072] Plasma samples were removed from the blood collection tubes and divided into two portions. Each portion was mixed with pH adjuster at an 8:1 ratio (800 μL plasma to 100 μL pH adjuster). One plasma sample was placed on ice, while the other was incubated at 37°C for 1 hour and then immediately placed on ice. The testing procedure and steps were performed according to the instructions of the kit used for the anticoagulant tubes. No enzyme inhibitor was added to the experimental group, while enzyme inhibitors were added to the control and positive control groups as normal. The results are shown in Table 3.

[0073] Table 3. Results of angiotensin I-responsive plasma renin activity (PRA) analysis

[0074]

[0075]

[0076] A t-test was performed on the measured values ​​of the three groups of samples, comparing the experimental group and the positive control group with the control group. The p-value between the experimental group and the control group was 0.6773 (greater than 0.05), indicating no significant difference, with a correlation coefficient of 0.9969. The p-value between the positive control group and the control group was 0.0469 (less than 0.05), but the correlation coefficient was 0.9238. Therefore, given the same storage time, the experimental group can meet the requirements for chemiluminescence immunoassay (CPI) determination of angiotensin I, while the positive control group requires immediate addition of the reagents from the kit after blood collection. Adding the reagents after a period of storage significantly affects the test results.

[0077] 3) The angiotensin II content was measured in plasma samples from the experimental group, control group and positive control group of the same patients according to the instructions of the kit used for the anticoagulant tube. No enzyme inhibitor was added to the experimental group, while enzyme inhibitors were added to the control group and positive control group as normal. The measurement results are shown in Table 4.

[0078] Table 4. Results of Angiotensin II Analysis

[0079]

[0080]

[0081] A t-test was performed on the measured values ​​of the three groups of samples, comparing the experimental group and the positive control group with the control group. The p-value between the experimental group and the control group was 0.9035 (greater than 0.05), indicating no significant difference, with a correlation coefficient of 0.9724. The p-value between the positive control group and the control group was 0.00001 (less than 0.05), with a correlation coefficient of 0.9022. Therefore, given the same storage time, the experimental group can meet the requirements for angiotensin II determination using chemiluminescence immunoassay, while the positive control group requires adding the corresponding reagent from the kit immediately after blood collection. Adding the reagent after a period of storage significantly affects the test results.

[0082] Example 4: An application of a vacuum blood collection tube for hypertension blood sample detection

[0083] I. Blood Collection

[0084] Following the formulation of 16.9 g / 100 mL dipotassium ethylenediaminetetraacetate, 8.4 g / 100 mL imidazolidinyl urea, 6.9 g / 100 mL 8-hydroxyquinoline sulfate, and 0.5 g / 100 mL enalapril maleate, with sterile water for injection as the solvent, a control hypertension blood sample protectant was prepared using the method described in Example 1. A control vacuum blood collection tube was then prepared using the control hypertension blood sample protectant.

[0085] Following the formulation of 16.9 g / 100 mL dipotassium ethylenediaminetetraacetate, 8.4 g / 100 mL imidazolidinyl urea, 6.9 g / 100 mL 8-hydroxyquinoline sulfate, and 2.0 g / 100 mL enalapril maleate, with sterile water for injection as the solvent, a control hypertension blood sample protectant II was prepared using the method described in Example 1. A control vacuum blood collection tube II was then prepared using the control hypertension blood sample protectant I.

[0086] Blood samples were stored and tested using both vacuum blood collection tubes (used for hypertension testing) and regular blood collection tubes, as detailed below:

[0087] Thirty volunteers underwent routine blood collection, with 5 mL of blood drawn from the antecubital vein. Four tubes were collected from each volunteer: one for the experimental group, one for the control group, one for control group one, and one for control group two. For the experimental group, control group one, and control group two, the blood samples were directly collected into the vacuum blood collection tubes (as described in Example 1 for hypertension blood sample detection), control vacuum blood collection tube one, and control vacuum blood collection tube two, respectively. The tubes were inverted several times and immediately placed in an ice-water bath or a 4°C refrigerator for 2 hours. For the control group, after the needle was removed, the blood was added to an anticoagulant tube containing anticoagulant (EDTA-K2 or EDTA-Na2). The tube cap was immediately opened, and 25 μL of 0.32 M dimercaprol solution and 50 μL of 0.34 M 8-hydroxyquinoline sulfate were added according to the kit instructions. The tube was then sealed, inverted several times to mix, and immediately placed in an ice-water bath or a 4°C refrigerator for 2 hours. This tube served as the control group blood collection tube.

[0088] The anticoagulant tubes and the kits used in this embodiment are the same as those in Example 2.

[0089] II. Blood Sample Processing

[0090] The levels of angiotensin I and angiotensin II in plasma samples from the same patients were measured using the following methods: (Experimental group blood collection tubes, control group blood collection tubes, and positive control group blood collection tubes).

[0091] 1) Take out the blood collection tubes of the experimental group, control group, control group 1 and control group 2 after the storage time, weigh 1700g, centrifuge for 10min, separate the plasma, and obtain the corresponding plasma samples.

[0092] 2) The angiotensin I content was measured in plasma samples from the experimental group, control group, control group 1, and control group 2 of the same patients, as detailed below:

[0093] Plasma samples were removed from the blood collection tubes and divided into two portions. Each portion was mixed with pH adjuster at an 8:1 ratio (800 μL plasma to 100 μL pH adjuster). One plasma sample was placed on ice, while the other was incubated at 37°C for 1 hour and then immediately placed on ice. The testing procedure and steps were performed according to the instructions of the kit used for the anticoagulant tubes. No enzyme inhibitors were added to the experimental group, control group 1, and control group 2. The control group received the normal addition of enzyme inhibitors. The results are shown in Table 5.

[0094] Table 5. Results of angiotensin I-responsive plasma renin activity (PRA) analysis

[0095]

[0096]

[0097] A t-test was performed on the measured values ​​of the four groups of samples, comparing the experimental group and control groups 1 and 2 with the control group. The p-value between the experimental group and the control group was 0.9857 (greater than 0.05), indicating no significant difference, with a correlation coefficient of 0.9973. The p-value between control group 1 and the control group was 0.0407 (less than 0.05), with a correlation coefficient of 0.9488. The p-value between control group 2 and the control group was 0.0458 (less than 0.05), with a correlation coefficient of 0.9544. Therefore, the experimental group meets the requirements for measuring angiotensin I levels, while control groups 1 and 2 show poor results and do not meet the usage requirements.

[0098] 3) The angiotensin II content was measured in plasma samples from the same patient group, control group, control group 1 and control group 2 according to the instructions of the kit used for the anticoagulant tube. No enzyme inhibitor was added to the experimental group, control group 1 and control group 2, while the control group was given enzyme inhibitor as normal. The measurement results are shown in Table 6.

[0099] Table 6. Results of Angiotensin II Analysis

[0100]

[0101]

[0102] A t-test was performed on the measured values ​​of the four groups of samples, comparing the experimental group with control group 1 and control group 2 with the control group. The p-value between the experimental group and the control group was 0.8658 (greater than 0.05), indicating no significant difference, with a correlation coefficient of 0.9983. The p-value between control group 1 and the control group was 0.000012 (less than 0.05), with a correlation coefficient of 0.9467. The p-value between control group 2 and the control group was 0.0001 (less than 0.05), with a correlation coefficient of 0.9562. Therefore, the experimental group met the requirements for measuring angiotensin II levels, while control groups 1 and 2 showed poor results and did not meet the usage requirements.

[0103] Examples 5-8: Blood sample preservatives for hypertension and vacuum blood collection tubes for hypertension blood sample testing

[0104] Examples 5-8 are respectively a blood sample preservative for hypertension and a vacuum blood collection tube for hypertension blood sample detection. They include a method for preparing a blood sample preservative for hypertension and a vacuum blood collection tube made therefrom for hypertension blood sample detection. The overall process is basically the same as that in Example 1, with the only difference being the amount of some raw materials and process parameters. See Table 7 for details.

[0105] Table 7. Summary of process parameters in Examples 5-8

[0106]

[0107] The contents of other parts of Examples 5 to 8 are the same as those of Example 1.

[0108] Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

Claims

1. A protective agent for detecting hypertension in blood samples, characterized in that, The protective agent for detecting hypertension blood samples comprises, by weight, 1-1.3 parts of enalapril maleate, 15.2-18.6 parts of anticoagulant, and 13.8-16.9 parts of complexing agent; wherein the complexing agent is imidazolidinyl urea and 8-hydroxyquinoline sulfate in a weight ratio of 7.5-9.2:6.3-7.

7. The protective agent used for blood sample testing for hypertension is pre-filled into the test tube and sealed, and the inside of the test tube is evacuated to a vacuum state.

2. The protective agent for detecting hypertension blood samples according to claim 1, characterized in that, The anticoagulant is dipotassium ethylenediaminetetraacetate.

3. The protective agent for detecting hypertension blood samples according to claim 1, characterized in that, The protective agent for hypertension blood sample testing is prepared by dissolving enalapril maleate, an anticoagulant, and a complexing agent in water for injection.

4. The protective agent for detecting hypertension blood samples according to claim 1, characterized in that, The protective agent used for blood sample testing for hypertension contains 15.2~18.6 g / 100 mL of dipotassium ethylenediaminetetraacetate, 7.5~9.2 g / 100 mL of imidazolidinyl urea, 6.3~7.7 g / 100 mL of 8-hydroxyquinoline sulfate, and 1.0~1.3 g / 100 mL of enalapril maleate.

5. A vacuum blood collection tube for detecting blood samples in cases of hypertension, characterized in that, The vacuum blood collection tube for hypertension blood sample testing is pre-filled with the protective agent for hypertension blood sample testing as described in any one of claims 1-4. During use, the vacuum blood collection tube for hypertension blood sample testing is used to directly add blood samples without adding enzyme inhibitors and is stored in an ice water bath or refrigerator.

6. The vacuum blood collection tube for hypertension blood sample detection according to claim 5, characterized in that, When the vacuum blood collection tubes used for hypertension blood sample testing are 3 mL in size, 34.0~41.6 μL of the hypertension blood sample protectant is sprayed on them; when the size is 5 mL, 56.7~69.3 μL of the hypertension blood sample protectant is sprayed on them; for other sizes, the corresponding amount of hypertension blood sample protectant is sprayed on them according to the proportion.

7. An application of a vacuum blood collection tube for detecting hypertension blood samples, characterized in that, The application involves directly preserving blood using the vacuum blood collection tube for hypertension blood sample testing as described in claim 5 or 6.

8. The application of the vacuum blood collection tube for hypertension blood sample detection according to claim 7, characterized in that, During blood preservation, the volume ratio of the blood sample preservative to the blood is 1:50~100.

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